1. Field of the Invention
The present invention relates generally to devices, systems, and methods for percutaneous sealing of a puncture site in tissue tracts. More specifically, the present invention relates to devices, systems, and methods for hemostasis of vascular puncture sites in human bodies.
Percutaneous access of blood vessels in the human body is routinely performed for diagnostics or interventional procedures such as coronary and peripheral angiography, angioplasty, atherectomies, placement of vascular stents, coronary retroperfusion and retroinfusion, cerebral angiograms, treatment of strokes, cerebral aneurysms, and the like. Patients undergoing these procedures are often treated with anti-coagulants such as heparin, thrombolytics, and the like, which make the closure and hemostasis process of the puncture site in the vessel wall at the completion of such interventional procedures more difficult to achieve.
Various devices have been introduced to provide hemostasis, however none have been entirely successful. Some devices utilize collagen or other biological plugs to seal the puncture site. Alternatively, sutures and/or staples have also been applied to close the puncture site. External foreign objects such as plugs, sutures, or staples however may cause tissue reaction, inflammation, and/or infection as they all “leave something behind” to achieve hemostasis.
There is also another class of devices that use the body's own natural mechanism to achieve hemostasis wherein no foreign objects are left behind. Such devices typically provide hemostasis by sealing the puncture site from the inside of the vessel wall wherein the device is left in place in the vessel lumen until hemostasis is reached and thereafter removed. Although such devices have achieved relative levels of success, removal of the device at times may disrupt the coagulant that is formed at the puncture site. This in turn may cause residual bleeding which requires the device user to apply a few minutes of external manual pressure at the puncture site after the removal of the device to achieve complete hemostasis.
Still further devices that also uses body's natural mechanism to achieve hemostasis comprise a locator on the inside of the vessel wall and a balloon to directly contact and seal the puncture site from the outside surface of the vessel wall. This balloon is directly against and in contact with the outside surface of the vessel wall for sealing the hole and achieving hemostasis. There are several drawbacks associated with direct contact and compression of the outside surface of the vessel wall. For example, excessive compression may cause herniation of the balloon through the puncture site into the vessel, which in turn may cause resumption of bleeding. Further, such devices may not be easily applied to severely tortuous vessels where direct access and contact with the vessel surface to seal the puncture may be difficult to achieve. Moreover, such devices may substantially disrupt the flow of blood in the vessel during its application. Further, intimate device contact with the puncture site of the vessel wall may not provide sufficient coagulant. Still further, removal of the device may cause disruption of the coagulant at the puncture site thereby increasing the chances for resumption of bleeding and hematoma formation (i.e., leaking of blood into interstitial space).
In light of the above, it would be desirable to provide improved devices, systems, and methods for complete hemostasis of a puncture site in a body lumen, particularly blood vessels of the human body. It would be particularly desirable if such devices, systems, and methods utilized the body's own natural healing mechanism to achieve hemostasis without disrupting coagulation formation at the puncture site. It would be further desirable if such devices, systems, and methods prevented any vessel herniation or vessel flow disruption. Further, such devices, systems, and methods should be easy to implement on a variety of vessel anatomies. At least some of theses objectives will be met by the devices, systems, and methods of the present invention described hereinafter.
2. Description of the Background Art
Expansible devices for use in blood vessels and tracts in the body are described in co-pending U.S. patent application Ser. No. 10/718,504, assigned to the assignee of the present application. The following U.S. patents and publications may be relevant to the present invention: U.S. Pat. Nos. 4,744,364; 4,852,568; 4,890,612; 5,108,421; 5,171,259; 5,258,000; 5,383,896; 5,419,765; 5,454,833; 5,626,601; 5,630,833; 5,634,936; 5,728,134; 5,861,003; 5,868,778; 5,951,583; 5,957,952; 6,017,359; 6,048,358; 6,296,657; U.S. Publication Nos. 2002/0133123 and 2003/0055454.
The full disclosures of each of the above mentioned references are incorporated herein by reference.